Sanofi calls for next Commission to boost Europe’s research capabilities [Advocacy Lab Content]

5 months ago 12

Sanofi is emphasising the strategic importance of Belgium in its pharmaceutical research and development initiatives, while also highlighting the EU’s potential to lead an artificial intelligence-driven revolution in medicine, particularly in the discovery and development of medicines.

Mark Canavan, Public Affairs Lead Europe at Sanofi, told Euractiv that Europe is at the forefront of emerging growth areas like immuno-science, where artificial intelligence (AI) significantly impacts the discovery and development of new treatments.

“As we see it, Europe is leading in emerging growth areas such as immuno-science where AI is having a particularly pronounced and transformative impact,” said Canavan.

“Immunoscience is our way of looking at the role the immune system plays not only in how diseases work but also how we can treat them,” said Houman Ashrafian, Executive Vice President, Head of Research and Development.

Regulatory and legislative support needed

The largest research-based pharmaceutical company headquartered in Europe is advancing a new class of medicines with the help of data science, computational expertise, and emerging technologies, including AI.

Sanofi’s R&D site in Ghent, Belgium, for example, is developing nanobodies for patients with immune-mediated respiratory diseases. Their researchers use AI to synthesise and compute tremendous amounts of data to help “crack the code” of disease.

The company recognises the need for regulatory and legislative support to maintain and enhance Europe’s competitive edge in the global pharma sector, observing that Europe has lost a significant share of global R&D investment over the past two decades, trailing behind the US and other emerging competitors.

“We cannot ignore this. It’s well acknowledged that there has been a silent erosion in the competitiveness and performance of the European pharma sector in recent decades,” Canavan points out.

Despite the challenges, Europe remains a strategic priority for Sanofi. “That is not going to change,” assured Canavan. The recent €120 million investment in biologics production in Geel, Belgium, underscores Sanofi’s commitment to the region.

Pharma package v. EU competitiveness

The company has expressed concerns about the pharma legislation proposals, highlighting potential downside risks.

However, elements of the new pharma package could significantly enhance business competitiveness. “Notable improvements include aligning EMA timelines more closely with the FDA, streamlining the PRIME scheme, and enabling regulatory innovation for new therapeutics through sandbox proposals,” Caravan explains.

Additionally, transitioning to electronic patient information leaflets across the union could substantially improve efficiency and resilience to shortages while also enhancing patient information dissemination, he shared.

Potential downside risks

Despite these potential benefits, there are notable concerns regarding the proposals, particularly concerning regulatory data protection.

“At this stage, there is a fear that the package might miss the opportunity to future-proof Europe’s innovation and regulatory landscape for tomorrow’s medicinal products,” Caravan said.

Beyond incentives, there are additional regulatory burdens to consider. The combined impact of supply and shortages provisions (SPPs or notifications), new environmental assessments, and potential new labelling requirements introduces significant new regulatory and bureaucratic challenges, along with additional capital investment requirements.

“At this stage, we fear that the package would be a missed opportunity for the medicines of tomorrow,” he added.

Impact on EU’s global competitiveness

For Sanofi, the impact of the pharma legislation needs to be considered within the broader context of the EU’s global competitiveness.

“As the Letta report highlighted, Europe’s resilience and security depend on preserving competitiveness in pharma R&D and industrial development, as well as deepening the ‘Single Market’ to address health inequalities, including access to diagnostics, medicines, and vaccines,” Caravan explained.

Commission proposals on biotech and biomanufacturing are a promising starting point for the next mandate. Sanofi hopes the next Commission will build on them in a biotech and biopharma Strategy.

“These proposals present an opportunity to build on Europe’s scientific excellence in areas such as immuno-science and to explore how existing capabilities can be multiplied. Furthermore, accelerating the speed of research by responsibly deploying AI at scale should be considered,” he concluded.

[By Nicole Verbeeck, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]